All US SARs CoV 2 vaccines (and SARs Cov 2 RT/PCR tests too) have been used in the US under a FDA Emergency Use Waver. An EUA. They have gone not through of the required product validation and safety tests. Which for vaccines usually take between 4 to 6 years.
None of the SARs Cov 2 RT/PCR tests used under a EUA have been validated using the standard viral test procedure of testing against 10% samples spiked with a reference virus sample. All are validated on the basis of a small number of field test swabs with no independent verification of swap sample status.
But thats not the real story. The real story is the legal power of a Federal Administration to declare an emergency which then allows the FDA to issue EUA's.
This is the Declaration of Emergency
Now the Act of Congress quoted in this Declaration was part of the Project Bioshied legalization passed to allow the Federal government to quickly respond to a terrorist biological, chemical, radiological or nuclear (BCRN) attack and get emergency use of medical devices etc.
The original bill only allowed a declaration of emergency in the case of a BCRN terrorist attack but the text of the Declaration of Emergency February 7, 2020, claims new powers passed under an amending bill of 2013.
2. As amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, Public Law 113-5, the Secretary may make determination of a public health emergency, or a significant potential for a public health emergency, under section 564 of the FD&C Act. The Secretary is no longer required to make a determination of a public health emergency in accordance with section 319 of the PHS Act, 42 U.S.C. 247d to support a determination or declaration made under section 564 of the FD&C Act.
The problem is, this power to declare and emergency is mentioned in the Summary of the Bill here..
https://www.congress.gov/bill/113th-congress/house-bill/307
..but not in the actual amending bill as finally passed into law.
[PART II follows..]
[PART II..]
Here is the Summary of the Amending Bill
(Sec. 302) Revises the Secretary's authority to allow the use of unapproved medical products or the unapproved use of an approved product. Authorizes the Secretary to make a declaration that the circumstances exist justifying such an authorization and base the determination on: (1) a (general) threat (rather than a specific threat as under current law), (2) a significant potential for a public health emergency, (3) the health and security of U.S. citizens abroad, and (4) the identification of a material threat sufficient to affect national security. Eliminates the one-year expiration date for such an authorization (thus allowing it to continue).
This current law as described here is consistent with the text of the final version of amending bill but not the Summary..
On the February 7, 2020 the Secretary only had the legal power to Declare an Emergency under the quoted statutes on the basis of a reasonable belief that a BCRN agent was an imminent treat to US security, military forces, or health of US citizen abroad. In the context of this bill any agent mentioned would be understood to be a BCRN agent not a new variant of an endemic viral respiratory illness.
So either the Secretary had substantial evidence on February 2'nd 2020 that SARs CoV 2 was a Biological Agent (which has a very specific legal meaning in US law) . Or else one of his legal staffers just read the Summary and did not actually read the law as finally passed. Would not be the first time the Summary did not fully conform to the passed law. Or that a staffer screwed up.
What this means is that not only are all SARs Cov2 vaccines (and tests) unlawful in the United States but I would also guess none of the product liability waivers given by the Federal Government to the vaccine makes are legal enforceable either.
This is going to make a lot of lawyers very rich over the coming decades.